Clinical trial · Observational
Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma
Hepatic Artery Infusion Pump Chemotherapy for Liver Metastases From Resected Pancreatic and Duodenal Adenocarcinoma: A Prospective Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
The goal of this observational study is to evaluate whether hepatic artery infusion pump (HAIP) chemotherapy can improve outcomes in patients with pancreatic or duodenal adenocarcinoma who have isolated or liver-dominant metastases after surgery and systemic chemotherapy. The main questions it aims to answer are: Does HAIP chemotherapy improve liver tumor response based on imaging criteria (RECIST)? What are the progression-free survival and overall survival outcomes in this patient population? Participants will: Undergo placement of a hepatic artery infusion pump as part of standard clinical care Receive floxuridine (FUDR)-based chemotherapy through the pump Have clinical data, imaging results, and laboratory markers (e.g., ctDNA, CEA, CA 19-9) collected from their medical records over time
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Adenocarcinoma | Ampulla of Vater Adenocarcinoma | ALIAS | 0.90 |
| Duodenal Adenocarcinoma | Duodenal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Duodenal Cancer | Malignant Duodenal Neoplasm | ALIAS | 0.90 |
| Pancreas Adenocarcinoma | Pancreatic Adenocarcinoma | ALIAS | 0.90 |
| Pancreas Cancer With Hepatic Metastase | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Floxuridine (FUDR) | Drug | — | UNRESOLVED |
| Hepatic Artery Infusion Pump (HAIP) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Hepatic Artery Pump Placement
- interventionNames
- Device: Hepatic Artery Infusion Pump (HAIP)
- Drug: Floxuridine (FUDR)
Primary outcomes (2)
- measure
- Progression-Free Survival
- timeFrame
- From pump placement to disease progression or death, up to 60 months
- description
- Time (months) from hepatic artery infusion (HAI) pump placement to disease progression or death, whichever occurs first.
- measure
- Hepatic Disease Control Rate
- timeFrame
- From pump placement to disease progression or death, up to 60 months
- description
- Percentage of patients with stable disease, partial response, or complete response based on RECIST criteria.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years * Histologically confirmed pancreatic or duodenal adenocarcinoma * Completed or currently receiving curative-intent treatment * Evidence of isolated or liver-dominant metastases (radiographic or clinical) * Deemed clinically eligible for hepatic artery infusion pump (HAIP) placement and floxuridine (FUDR)-based chemotherapy by a multidisciplinary oncology team * Scheduled for HAIP placement at AdventHealth Orlando Exclusion Criteria: \- Patients who are clinically ineligible for HAIP placement or FUDR therapy are excluded
References
Publications (4)
- BACKGROUNDHashimoto A, Nishiofuku H, Tanaka T, Sho M, Anai H, Nakajima Y, Kichikawa K. Safety and optimal management of hepatic arterial infusion chemotherapy after pancreatectomy for pancreatobiliary cancer. AJR Am J Roentgenol. 2012 Apr;198(4):923-30. doi: 10.2214/AJR.11.6751. PMID 22451562
- BACKGROUNDKato Y, Tsuyuki A, Kikuchi K, Tokuyama J, Kurihara N, Kumamoto Y, Fujishiro Y, Ebinuma H. Continuous hepatic arterial infusion chemotherapy for liver metastasis from biliary tract and pancreatic cancers. Anticancer Res. 2005 Jan-Feb;25(1B):477-82. PMID 15816615
- BACKGROUNDEndo S, Kawaguchi S, Terada S, Shirane N. Hepatic Arterial Infusion Chemotherapy for Liver Metastases Following Standard Chemotherapy for Pancreatic Cancer. Intern Med. 2021 Jan 15;60(2):223-229. doi: 10.2169/internalmedicine.5449-20. Epub 2020 Sep 19. PMID 32963157
- BACKGROUNDKemeny N, Huang Y, Cohen AM, Shi W, Conti JA, Brennan MF, Bertino JR, Turnbull AD, Sullivan D, Stockman J, Blumgart LH, Fong Y. Hepatic arterial infusion of chemotherapy after resection of hepatic metastases from colorectal cancer. N Engl J Med. 1999 Dec 30;341(27):2039-48. doi: 10.1056/NEJM199912303412702. PMID 10615075